HealthyPhase 1NCT02226926
Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
A Phase 1 study testing Aggrenox, Persantin Retard and Acetylsalicylic acid in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aggrenox, Persantin Retard and Acetylsalicylic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Sep 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females/males
- Age range from 18 to 60
- Volunteers will have given their written informed consent in accordance with local ethics committee and local legislation
Who cannot join
- Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
- Known history of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Drug intake with long half-life (> 24 hours), < 1 month prior to administration or during the trial
Show all 19Show fewer
- Volunteers received any other drugs which might influence the results of the trial, < 10 days prior to administration or during the trial
- Participation in another study with an investigational drug, < 1 month prior to administration or during the trial
- Smoking more than 15 cigarettes or 4 cigars or 4 pipes/day
- Drinking more than 60 g of alcohol per day
- Unable to refrain from excessive consumption of methylxanthine containing drinks or food
- Drug addiction
- Blood donation (> 400 ml), < 4 weeks prior to administration or during the trial
- Participation in excessive physical activities, < 5 days prior to administration or during the trial
- For female volunteers:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (acceptable: oral contraceptives, condoms, etc.)
- Lactation period
About this study
Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels
- Conditions
- Healthy
- Being tested
- Aggrenox, Persantin Retard, Acetylsalicylic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AggrenoxDrug
Persantin RetardDrug
Acetylsalicylic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Aggrenox | Experimental | Dipyridamole extended release / Acetylsalicylic acid Receives: Drug: Aggrenox |
| Persantin Retard | Active comparator | Dipyridamole extended release Receives: Drug: Persantin Retard |
| Acetylsalicylic acid | Active comparator | Not described Receives: Drug: Acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
VASP-Ser239 / VASP-Ser157-phosphorylation
induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)
Measured: up to day 10
Secondary outcomes (1)
Change in Dipyridamole plasma levels
by High Performance Liquid Chromatography (HPLC)
Measured: up to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startJul 2000
- Primary completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226926
- Sponsor's protocol ID
- 9.142
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02226926
- Acronym / sponsor ID
- 9.142
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Sep 2000 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aggrenox | Experimental | Drug: AggrenoxDipyridamole extended release / Acetylsalicylic acid |
| Persantin Retard | Active comparator | Drug: Persantin RetardDipyridamole extended release |
| Acetylsalicylic acid | Active comparator | Drug: Acetylsalicylic acid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy females/males
- Age range from 18 to 60
- Volunteers will have given their written informed consent in accordance with local ethics committee and local legislation
Key exclusion criteria (19 listed)
- Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
- Known history of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggrenox | Drug | Aggrenox |
| Persantin Retard | Drug | Persantin Retard |
| Acetylsalicylic acid | Drug | Acetylsalicylic acid |
Primary outcome
VASP-Ser239 / VASP-Ser157-phosphorylation
Time frame: up to day 10
induced by sodium nitroprusside (SNP) 0.5µM or SNP 0.3µM and prostaglandin E1 (PG-E1) 0.3nM (Western Blot)
1 secondary outcome
Change in Dipyridamole plasma levels
Time frame: up to day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aggrenox, Persantin Retard and Acetylsalicylic acid in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VASP-Ser239 / VASP-Ser157-phosphorylation (time frame: up to day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.